Transforming From Supply-Led To A Demand-Led Model To Support Commercial Gene Therapies

Cell and gene therapies (CGT) are unique in that they often target diseases or conditions for which no other therapy alternative exists, which makes their approval and commercialization even more pressing for the affected patients. These new kinds of therapies are also unique in how they are challenging conventional supply chain models, exerting pressure on established supply and distribution processes and forcing providers to rapidly adapt their services.

In the case of the gene therapies (GT) supply chains, the focus is entirely patient-centric and the ‘volumes’ can often be as low as 1 dose per batch/lot. To deliver against this requirement, the supply and distribution model needs to be much more flexible and precise, as gene therapies demand a complete reimagining and transformation of the traditional model.

Sharp Clinical has been contracted by a client to support the anticipated commercial launch of their portfolio of gene therapies. This new challenge led to a cross-functional and holistic adaptation of Sharp’s existing packaging, labeling and distribution processes. To support this client, Sharp needed to be able to respond immediately to patient-driven supply needs, without compromising on quality.